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临床试验/NCT01534338
NCT01534338已完成1 期

A Randomized Controlled Trial Testing the Effect of Mindfulness Practices Versus Sleep Education on Sleep and Inflammation Among Older Adults With Sleep Problems

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2012年2月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
48
试验地点
1
主要终点
Sleep

研究概览

简要总结

The primary aim of the study is to test the effect of mindfulness training on sleep parameters among older adults with insomnia symptoms

The secondary aims are to examine if changes in mindfulness meditation practice (daily log) and level of mindfulness (self-report) are associated with changes in sleep parameters, and to determine if mindfulness training is associated with in vitro biological markers of peripheral inflammation

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Men and women (all races and ethnicities) 55 years of age and older
  • •Have current problems sleeping
  • •Fluent in English
  • •Able to understand and provide signed informed consent
  • •Willing to be randomly assigned to treatment condition

排除标准

  • •Individuals currently undergoing major medical treatment such as surgery, radiation, or immunotherapy
  • •Individuals living outside of a 20 mile radius from the UCLA Medical Center
  • •Individuals with current substance dependence

研究组 & 干预措施

Mindfulness Meditation

Experimental

The MAPs program is based on experiential training in mindfulness meditation offered at the UCLA Mindful Awareness Research Center (MARC). A certified UCLA instructor will provide didactic training in mindfulness meditation in a group-based setting. Participants will be guided through in-class meditation practices and will be assigned daily meditation homework. Active program components include sitting and walking somatosensory-focused meditation, audio-guided body scan meditation, and loving kindness meditation. Participants will attend weekly 2-hour classes for a total of 6 weeks and participants will monitor their sleep with a daily sleep diary. In addition to the MAPs training, sleep hygiene material will also be presented to match the sleep hygiene material in the sleep education condition.

干预措施: Mindfulness Meditation (Behavioral)

Sleep Education

Active Comparator

The sleep education condition is founded on knowledge acquisition. In the sleep seminar condition, a trained health educator will provide didactic presentations on sleep, sleep hygiene, sleep problems, and potential solutions to sleep problems in a group-based setting. Active components of sleep education include increasing knowledge of sleep biology, identifying characteristics of healthy and unhealthy sleep, sleep problems, and self-monitoring of sleep behavior. Participants attend weekly 2-hour classes for a total of 6 weeks and participants will monitor their sleep with a daily sleep diary. The health education condition is comparable to MAPs in terms of time, attention, group support, and participant expectancy of a benefit in sleep parameters.

干预措施: Sleep Education (Behavioral)

结局指标

主要结局

Sleep

时间窗: Within 2 weeks post-intervention

Primary sleep outcomes to be assessed include Daily sleep diary, Pittsburgh Sleep Quality Index, Fatigue Symptom Inventory, Insomnia Severity Index, and Pre-Sleep Arousal Scale

次要结局

  • Mindfulness(Within 2 weeks post-intervention)
  • Inflammatory Biology(Within 2 weeks post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David S. Black

Principal Investigator

University of California, Los Angeles

研究点 (1)

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